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1. The case for simplifying and using absolute targets for viral hepatitis elimination goals

Author

Razavi, H. Blach, S. Razavi-Shearer, D. Abaalkhail, F. Abbas, Z. Abdallah, A. Abrao Ferreira, P. Abu Raddad, L.J. Adda, D. Agarwal, K. Aghemo, A. Ahmed, A. Al-Busafi, S.A. Al-hamoudi, W. Al-Kaabi, S. Al-Romaihi, H. Aljarallah, B. AlNaamani, K. Alqahtani, S. Alswat, K. Altraif, I. Asselah, T. Bacon, B. Bessone, F. Bizri, A.R. Block, T. Bonino, F. Brandão-Mello, C.E. Brown, K. Bruggmann, P. Brunetto, M.R. Buti, M. Cabezas, J. Calleja, J.L. Castro Batänjer, E. Chan, H.L.-Y. Chang, H. Chen, C.-J. Christensen, P.B. Chuang, W.-L. Cisneros, L. Cohen, C. Colombo, M. Conway, B. Cooper, C. Craxi, A. Crespo, J. Croes, E. Cryer, D. Cupertino de Barros, F.P. Derbala, M. Dillon, J. Doss, W. Dou, X. Doyle, J. Duberg, A.-S. Dugan, E. Dunn, R. Dusheiko, G. El Khayat, H. El-Sayed, M.H. Eshraghian, A. Esmat, G. Esteban Mur, R. Ezzat, S. Falconer, K. Fassio, E. Ferrinho, P. Flamm, S. Flisiak, R. Foster, G. Fung, J. García-Samaniego, J. Gish, R.G. Gonçales, F. Halota, W. Hamoudi, W. Hassany, M. Hatzakis, A. Hay, S. Himatt, S. Hoepelman, I.M. Hsu, Y.-C. Hui, Y.T. Hunyady, B. Jacobson, I. Janjua, N. Janssen, H. Jarcuska, P. Kabagambe, K. Kanto, T. Kao, J.-H. Kaymakoglu, S. Kershenobich, D. Khamis, F. Kim, D.J. Kim, D.Y. Kondili, L.A. Kottilil, S. Kramvis, A. Kugelmas, M. Kurosaki, M. Lacombe, K. Lagging, M. Lao, W.-C. Lavanchy, D. Lazarus, J.V. Lee, A. Lee, S.S. Levy, M. Liakina, V. Lim, Y.-S. Liu, S. Maddrey, W. Malekzadeh, R. Marinho, R.T. Mathur, P. Maticic, M. Mendes Correa, M.C. Mera, J. Merat, S. Mogawer, S. Mohamed, R. Muellhaupt, B. Muljono, D. Mostafa, I. Nahum, M.S. Nawaz, A. Negro, F. Ninburg, M. Ning, Q. Ntiri- Reid, B. Nymadawa, P. Oevrehus, A. Ormeci, N. Orrego, M. Osman, A. Oyunsuren, T. Pan, C. Papaevangelou, V. Papatheodoridis, G. Popping, S. Prasad, P. Prithiviputh, R. Qureshi, H. Ramji, A. Razavi-Shearer, K. Reddy, R. Remak, W. Richter, C. Ridruejo, E. Robaeys, G. Roberts, S. Roberts, L. Roudot-Thoraval, F. Saab, S. Said, S. Salamat, A. Sanai, F. Sanchez-Avila, J.F. Schiff, E. Schinazi, R. Sebastiani, G. Seguin-Devaux, C. Shanmugam, R.P. Sharara, A. Shilton, S. Shouval, D. Sievert, W. Simonova, M. Sohrabpour, A.A. Sonderup, M. Soza, A. Wendy Spearman, C. Steinfurth, N. Sulkowski, M. Tan, S.-S. Tanaka, J. Tashi, D. Thein, H.-H. Thompson, P. Tolmane, I. Toy, M. Valantinas, J. Van de Vijver, D. Vélez-Möller, P. Vince, A. Waked, I. Wang, S. Wedemeyer, H. Wong, V. Xie, Q. Yamada, S. Yang, H.-I. Yesmembetov, K. Yilmaz, Y. Younossi, Z. Yu, M.-L. Yuen, M.-F. Yurdaydin, C. Yusuf, A. Zekry, A. Zeuzem, S. Polaris Observatory Collaborators

Subjects
digestive system diseases
Abstract

The 69th World Health Assembly endorsed the Global Health Sector Strategy for Viral Hepatitis, embracing a goal to eliminate hepatitis infection as a public health threat by 2030. This was followed by the World Health Organization's (WHO) global targets for the care and management of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. These announcements and targets were important in raising awareness and calling for action; however, tracking countries’ progress towards these elimination goals has provided insights to the limitations of these targets. The existing targets compare a country's progress relative to its 2015 values, penalizing countries who started their programmes prior to 2015, countries with a young population, or countries with a low prevalence. We recommend that (1) WHO simplify the hepatitis elimination targets, (2) change to absolute targets and (3) allow countries to achieve these disease targets with their own service coverage initiatives that will have the maximum impact. The recommended targets are as follows: reduce HCV new chronic cases to ≤5 per 100 000, reduce HBV prevalence among 1-year-olds to ≤0.1%, reduce HBV and HCV mortality to ≤5 per 100 000, and demonstrate HBV and HCV year-to-year decrease in new HCV- and HBV-related HCC cases. The objective of our recommendations is not to lower expectations or diminish the hepatitis elimination standards, but to provide clearer targets that recognize the past and current elimination efforts by countries, help measure progress towards true elimination, and motivate other countries to follow suit. © 2020 John Wiley & Sons Ltd

Published
2021

2. The case for simplifying and using absolute targets for viral hepatitis elimination goals.

Author

Razavi H., Blach S., Razavi-Shearer D., Abaalkhail F., Abbas Z., Abdallah A., Abrao Ferreira P., Abu Raddad L.J., Adda D., Agarwal K., Aghemo A., Ahmed A., Al-Busafi S.A., Al-hamoudi W., Al-Kaabi S., Al-Romaihi H., Aljarallah B., AlNaamani K., Alqahtani S., Alswat K., Altraif I., Asselah T., Bacon B., Bessone F., Bizri A.R., Block T., Bonino F., Brandao-Mello C.E., Brown K., Bruggmann P., Brunetto M.R., Buti M., Cabezas J., Calleja J.L., Castro Batanjer E., Chan H.L.-Y., Chang H., Chen C.-J., Christensen P.B., Chuang W.-L., Cisneros L., Cohen C., Colombo M., Conway B., Cooper C., Craxi A., Crespo J., Croes E., Cryer D., Cupertino de Barros F.P., Derbala M., Dillon J., Doss W., Dou X., Doyle J., Duberg A.-S., Dugan E., Dunn R., Dusheiko G., El Khayat H., El-Sayed M.H., Eshraghian A., Esmat G., Esteban Mur R., Ezzat S., Falconer K., Fassio E., Ferrinho P., Flamm S., Flisiak R., Foster G., Fung J., Garcia-Samaniego J., Gish R.G., Goncales F., Halota W., Hamoudi W., Hassany M., Hatzakis A., Hay S., Himatt S., Hoepelman I.M., Hsu Y.-C., Hui Y.T., Hunyady B., Jacobson I., Janjua N., Janssen H., Jarcuska P., Kabagambe K., Kanto T., Kao J.-H., Kaymakoglu S., Kershenobich D., Khamis F., Kim D.J., Kim D.Y., Kondili L.A., Kottilil S., Kramvis A., Kugelmas M., Kurosaki M., Lacombe K., Lagging M., Lao W.-C., Lavanchy D., Lazarus J.V., Lee A., Lee S.S., Levy M., Liakina V., Lim Y.-S., Liu S., Maddrey W., Malekzadeh R., Marinho R.T., Mathur P., Maticic M., Mendes Correa M.C., Mera J., Merat S., Mogawer S., Mohamed R., Muellhaupt B., Muljono D., Mostafa I., Nahum M.S., Nawaz A., Negro F., Ninburg M., Ning Q., Ntiri- Reid B., Nymadawa P., Oevrehus A., Ormeci N., Orrego M., Osman A., Oyunsuren T., Pan C., Papaevangelou V., Papatheodoridis G., Popping S., Prasad P., Prithiviputh R., Qureshi H., Ramji A., Razavi-Shearer K., Reddy R., Remak W., Richter C., Ridruejo E., Robaeys G., Roberts S., Roberts L., Roudot-Thoraval F., Saab S., Said S., Salamat A., Sanai F., Sanchez-Avila J.F., Schiff E., Schinazi R., Sebastiani G., Seguin-Devaux C., Shanmugam R.P., Sharara A., Shilton S., Shouval D., Sievert W., Simonova M., Sohrabpour A.A., Sonderup M., Soza A., Wendy Spearman C., Steinfurth N., Sulkowski M., Tan S.-S., Tanaka J., Tashi D., Thein H.-H., Thompson P., Tolmane I., Toy M., Valantinas J., Van de Vijver D., Velez-Moller P., Vince A., Waked I., Wang S., Wedemeyer H., Wong V., Xie Q., Yamada S., Yang H.-I., Yesmembetov K., Yilmaz Y., Younossi Z., Yu M.-L., Yuen M.-F., Yurdaydin C., Yusuf A., Zekry A., Zeuzem S., Razavi H., Blach S., Razavi-Shearer D., Abaalkhail F., Abbas Z., Abdallah A., Abrao Ferreira P., Abu Raddad L.J., Adda D., Agarwal K., Aghemo A., Ahmed A., Al-Busafi S.A., Al-hamoudi W., Al-Kaabi S., Al-Romaihi H., Aljarallah B., AlNaamani K., Alqahtani S., Alswat K., Altraif I., Asselah T., Bacon B., Bessone F., Bizri A.R., Block T., Bonino F., Brandao-Mello C.E., Brown K., Bruggmann P., Brunetto M.R., Buti M., Cabezas J., Calleja J.L., Castro Batanjer E., Chan H.L.-Y., Chang H., Chen C.-J., Christensen P.B., Chuang W.-L., Cisneros L., Cohen C., Colombo M., Conway B., Cooper C., Craxi A., Crespo J., Croes E., Cryer D., Cupertino de Barros F.P., Derbala M., Dillon J., Doss W., Dou X., Doyle J., Duberg A.-S., Dugan E., Dunn R., Dusheiko G., El Khayat H., El-Sayed M.H., Eshraghian A., Esmat G., Esteban Mur R., Ezzat S., Falconer K., Fassio E., Ferrinho P., Flamm S., Flisiak R., Foster G., Fung J., Garcia-Samaniego J., Gish R.G., Goncales F., Halota W., Hamoudi W., Hassany M., Hatzakis A., Hay S., Himatt S., Hoepelman I.M., Hsu Y.-C., Hui Y.T., Hunyady B., Jacobson I., Janjua N., Janssen H., Jarcuska P., Kabagambe K., Kanto T., Kao J.-H., Kaymakoglu S., Kershenobich D., Khamis F., Kim D.J., Kim D.Y., Kondili L.A., Kottilil S., Kramvis A., Kugelmas M., Kurosaki M., Lacombe K., Lagging M., Lao W.-C., Lavanchy D., Lazarus J.V., Lee A., Lee S.S., Levy M., Liakina V., Lim Y.-S., Liu S., Maddrey W., Malekzadeh R., Marinho R.T., Mathur P., Maticic M., Mendes Correa M.C., Mera J., Merat S., Mogawer S., Mohamed R., Muellhaupt B., Muljono D., Mostafa I., Nahum M.S., Nawaz A., Negro F., Ninburg M., Ning Q., Ntiri- Reid B., Nymadawa P., Oevrehus A., Ormeci N., Orrego M., Osman A., Oyunsuren T., Pan C., Papaevangelou V., Papatheodoridis G., Popping S., Prasad P., Prithiviputh R., Qureshi H., Ramji A., Razavi-Shearer K., Reddy R., Remak W., Richter C., Ridruejo E., Robaeys G., Roberts S., Roberts L., Roudot-Thoraval F., Saab S., Said S., Salamat A., Sanai F., Sanchez-Avila J.F., Schiff E., Schinazi R., Sebastiani G., Seguin-Devaux C., Shanmugam R.P., Sharara A., Shilton S., Shouval D., Sievert W., Simonova M., Sohrabpour A.A., Sonderup M., Soza A., Wendy Spearman C., Steinfurth N., Sulkowski M., Tan S.-S., Tanaka J., Tashi D., Thein H.-H., Thompson P., Tolmane I., Toy M., Valantinas J., Van de Vijver D., Velez-Moller P., Vince A., Waked I., Wang S., Wedemeyer H., Wong V., Xie Q., Yamada S., Yang H.-I., Yesmembetov K., Yilmaz Y., Younossi Z., Yu M.-L., Yuen M.-F., Yurdaydin C., Yusuf A., Zekry A., and Zeuzem S.

Abstract

The 69th World Health Assembly endorsed the Global Health Sector Strategy for Viral Hepatitis, embracing a goal to eliminate hepatitis infection as a public health threat by 2030. This was followed by the World Health Organization's (WHO) global targets for the care and management of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. These announcements and targets were important in raising awareness and calling for action; however, tracking countries' progress towards these elimination goals has provided insights to the limitations of these targets. The existing targets compare a country's progress relative to its 2015 values, penalizing countries who started their programmes prior to 2015, countries with a young population, or countries with a low prevalence. We recommend that (1) WHO simplify the hepatitis elimination targets, (2) change to absolute targets and (3) allow countries to achieve these disease targets with their own service coverage initiatives that will have the maximum impact. The recommended targets are as follows: reduce HCV new chronic cases to <=5 per 100 000, reduce HBV prevalence among 1-year-olds to <=0.1%, reduce HBV and HCV mortality to <=5 per 100 000, and demonstrate HBV and HCV year-to-year decrease in new HCV- and HBV-related HCC cases. The objective of our recommendations is not to lower expectations or diminish the hepatitis elimination standards, but to provide clearer targets that recognize the past and current elimination efforts by countries, help measure progress towards true elimination, and motivate other countries to follow suit.Copyright © 2020 John Wiley & Sons Ltd

Published
2021

4. International Autoimmune Hepatitis Group* Report: review of criteria for diagnosis of autoimmune hepatitis

Author

Alvarez, F., Berg, P. A., Bianchi, F. B., Bianchi, L., Burroughs, A. K., Cancado, E. L., Chapman, R. W., Cooksley, W. G. E., Czaja, A. J., Desmet, V. J., Donaldson, P. T., Eddleston, A. L. W. F., Fainboim, L., Heathcote, J., Homberg, J.-C., Hoofnagle, J. H., Kakumu, S., Krawitt, E. L., Mackay, I. R., MacSween, R. N. M., Maddrey, W. C., Manns, M. P., McFarlane, I. G., Meyer zum Büschenfelde, K.-H., Mieli-Vergani, G., Nakanuma, Y., Nishioka, M., Penner, E., Porta, G., Portmann, B. C., Reed, W. D., Rodes, J., Schalm, S. W., Scheuer, P. J., Schrumpf, E., Seki, T., Toda, G., Tsuji, T., Tygstrup, N., Vergani, D., and Zeniya, M.

Published
1999

6. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis

Author

Paul, O'Connor, Wolinsky, Jerry S., Christian, Confavreux, Giancarlo, Comi, Ludwig, Kappos, Olsson, Tomas P., Hadj, Benzerdjeb, Philippe, Truffinet, Lin, Wang, Aaron, Miller, Temso Trial Group Reingold, Freedman Ms S., Cutter, G., Antel, J., Barkhof, F., Maddrey, W., Ravnborg, M., Schenker, S., O'Connor, P., Wolinsky, J. S., Confavreux, C., Comi, G., Kappos, L., Olsson, T. P., Miller, A., Freedman, Mark S., Narayana, P. A., Nelson, F., Vainrub, I., Datta, S., He, R., Gates, B., Ton, K., Wamil, B., Truffinet, P., Igau, B., Nicolas, V., Notelet, L., Payrard, S., Wijnand, P., Devore, S., H. H., Li, Osho, T., Wang, L., Wei, L., Dukovic, D., Ling, Y., Benzerdjeb, H., Mednikova, Z., Trabelsi, N., Musset, M., Merrill, D., Turpault, S., Williams, B., Nortmeyer, H., Kirst, E., Witthaus, E., Chen, S., Maida, E., Auff, E., Fazekas, F., Berger, T., Bhan, V., Bouchard, J. P., Duquette, P., Freedman, M., Grand'Maison, F., Kremenchutzky, M., Bourque, C., Marrie, R. A., Melanson, M., Patry, D., Oger, J., Stefanelli, M., Jacques, F., Venegas, P., Miranda, M., Barrientos, N., Tenhamm, E., Gloger, S., Rohde, G., Mares, J., Frederiksen, J., Stenager, E., Haldre, S., Gross Paju, K., Elovaara, I., Sumelahti, M. L., Erälinna, J. P., Farkkila, M., Harno, H., Reunanen, M., Jolma, T., Camu, W., Clavelou, P., Magy, L., Debouverie, M., Edan, G., Lebrun Frenay, C., Moreau, T., Pelletier, J., Roullet, E., Alamowitch, S., Clanet, M., Hautecoeur, P., Damier, P., Rumbach, L., Chan, A., Schimrigk, S., Haas, J., Lensch, E., Diener, H., Limmroth, V., Anders, D., Berghoff, M., Oschmann, P., Stangel, M., Frese, A., Kiefer, R., Marziniak, M., Zettl, U., Stark, E., Jendroska, K., Reifschneider, G., Amato, M. P., Cosi, V., Gallo, P., Gasperini, Claudio, Ghezzi, A., Trojano, M., Pozzilli, Carlo, Montanari, E., Zwanikken, C. P., Jongen, P. J., Van Munster, E. T., Hupperts, R. M., Anten, B., Sanders, E. A., Celius, E., Hovdal, H., Krogseth, S. B., Kozubski, W., Kwiecinski, H., Czlonkowska, A., Stelmasiak, Z., Selmaj, K., Hasiec, T., Fryze, W., Drozdowski, W., Kochanowicz, J., Cunha, L., De Sa, J., Sena, A. H., Odinak, M., Skoromets, A., Gusev, E., Boiko, A., Lashch, N., Stolyarov, I., Belova, A., Malkova, N., Doronin, B., Yakupov, E., Brundin, L., Hillert, J., Karabudak, R., Irkec, C., Idiman, E., Turan, O., Efendi, H., Gedizlioglu, M., Buchakchyyska, N., Goloborodko, A., Ipatov, A., Kobets, S., Lebedynets, V., Moskovko, S., Sanotskyy, Y., Smolanka, V., Yavorskaya, V., Bates, D., Evangelou, N., Hawkins, C., Mclean, B., O'Riordan, J., Price, S., Turner, B., Barnes, D., Zajicek, J., Honeycutt, W., Khan, O., Spikol, L., Stevens, J., Klinische Neurowetenschappen, and RS: MHeNs School for Mental Health and Neuroscience

Subjects
medicine.medical_specialty, biology, Nausea, business.industry, Incidence (epidemiology), Placebo-controlled study, General Medicine, Placebo, Gastroenterology, Surgery, chemistry.chemical_compound, Alanine transaminase, chemistry, Internal medicine, Relative risk, Teriflunomide, medicine, biology.protein, medicine.symptom, business, Leflunomide, medicine.drug
Abstract

Teriflunomide reduced the annualized relapse rate (0.54 for placebo vs. 0.37 for teri flunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (P

Published
2011
Full Text
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8. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis

Author

O'Connor, P, Wolinsky, Js, Confavreux, C, Comi, G, Kappos, L, Olsson, Tp, Benzerdjeb, H, Truffinet, P, Wang, L, Miller, A, Freedman, Ms, Reingold, S, Cutter, G, Antel, J, Barkhof, F, Maddrey, W, Ravnborg, M, Schenker, S, Narayana, Pa, Nelson, F, Vainrub, I, Datta, S, He, R, Gates, B, Ton, K, Wamil, B, Igau, B, Nicolas, V, Notelet, L, Payrard, S, Wijnand, P, Devore, S, Li, Hh, Osho, T, Wei, L, Dukovic, D, Ling, Y, Mednikova, Z, Trabelsi, N, Musset, M, Merrill, D, Turpault, S, Williams, B, Nortmeyer, H, Kirst, E, Witthaus, E, Chen, S, Maida, E, Auff, E, Fazekas, F, Berger, T, Bhan, V, Bouchard, Jp, Duquette, P, Grand'Maison, F, Kremenchutzky, M, Bourque, C, Marrie, Ra, Melanson, M, Patry, D, Oger, J, Stefanelli, M, Jacques, F, Venegas, P, Miranda, M, Barrientos, N, Tenhamm, E, Gloger, S, Rohde, G, Mares, J, Frederiksen, J, Stenager, E, Haldre, S, Gross Paju, K, Elovaara, I, Sumelahti, Ml, Erälinna, Jp, Färkkilä, M, Harno, H, Reunanen, M, Jolma, T, Camu, W, Clavelou, P, Magy, L, Debouverie, M, Edan, G, Lebrun Frenay, C, Moreau, T, Pelletier, J, Roullet, E, Alamowitch, S, Clanet, M, Hautecoeur, P, Damier, P, Rumbach, L, Chan, A, Schimrigk, S, Haas, J, Lensch, E, Diener, H, Limmroth, V, Anders, D, Berghoff, M, Oschmann, P, Stangel, M, Frese, A, Kiefer, R, Marziniak, M, Zettl, U, Stark, E, Jendroska, K, Reifschneider, G, Amato, Mp, Cosi, V, Gallo, Paolo, Gasperini, C, Ghezzi, A, Trojano, M, Pozzilli, C, Montanari, E, Zwanikken, Cp, Jongen, Pj, Van Munster ET, Hupperts, Rm, Anten, B, Sanders, Ea, Celius, E, Hovdal, H, Krogseth, Sb, Kozubski, W, Kwiecinski, H, Czlonkowska, A, Stelmasiak, Z, Selmaj, K, Hasiec, T, Fryze, W, Drozdowski, W, Kochanowicz, J, Cunha, L, De Sá, J, Sena, Ah, Odinak, M, Skoromets, A, Gusev, E, Boiko, A, Lashch, N, Stolyarov, I, Belova, A, Malkova, N, Doronin, B, Yakupov, E, Brundin, L, Hillert, J, Karabudak, R, Irkec, C, Idiman, E, Turan, O, Efendi, H, Gedizlioglu, M, Buchakchyyska, N, Goloborodko, A, Ipatov, A, Kobets, S, Lebedynets, V, Moskovko, S, Sanotskyy, Y, Smolanka, V, Yavorskaya, V, Bates, D, Evangelou, N, Hawkins, C, Mclean, B, O'Riordan, J, Price, S, Turner, B, Barnes, D, Zajicek, J, Honeycutt, W, Khan, O, Spikol, L, and Stevens, J.

Published
2011

12. Characterization and epitope mapping of human monoclonal antibodies to PDC-E2, the immunodominant autoantigen of primary biliary cirrhosis

Author

Leung, PSC, Krams, S, Munoz, S, Surh, CP, Ansari, A, Kenny, T, Robbins, DL, Fung, J, Starzl, TE, Maddrey, W, Coppel, RL, Gershwin, ME, Leung, PSC, Krams, S, Munoz, S, Surh, CP, Ansari, A, Kenny, T, Robbins, DL, Fung, J, Starzl, TE, Maddrey, W, Coppel, RL, and Gershwin, ME

Abstract

Further to define the epitopes of PDC-E2, the major autoantigen in primary biliary cirrhosis (PBC), we have developed and characterized five human monoclonal antibodies. These antibodies were derived by fusing a regional hepatic lymph node from a patient with PBC with the mouse human heterohybrid cell line F3B6. Previous studies of epitope mapping of PDC-E2 have relied on whole sera and have suggested that the immunodominant epitope lies within the inner lipoyl domain of the molecule. However, selective absorption studies using whole sera and a series of overlapping recombinant peptides of PDC-E2 have suggested that the epitope may also include a large conformational component. Moreover, several laboratories have suggested that autoantibodies against the 2-oxo acids dehydrogenase autoantigens are cross-reactive. The five monoclonal antibodies generated included three IgG2a and two IgM antibodies and were studied for antigen specificity using recombinant PDC-E2, recombinant BCKD-E2, histone, dsDNA, IgG (Fc), collagen and a recombinant irrelevant liver specific control, the F alloantigen. The antibodies were also used to probe blots of human, bovine, mouse and rat mitochondria. Finally, fine specificity was studied by selective ELISA and absorption against overlapping expressing fragments of PDC-E2. All five monoclonals, but none of the other mitochondrial autoantigens were specific for PDC-E2. In fact, although affinity purified antibodies to PDC-E2 from patients with PBC cross-reacted with protein X, the human monoclonals did not, suggesting that protein X contains an epitope distinct from that found on PDC-E2. Additionally, all three IgG2 monoclonals recognized distinct epitopes within the inner lipoyl domain of PDC-E2. © 1992.

Published
1992

14. A randomized double-blind, placebo-controlled trial ursodeoxycholic acid in primary biliary cirrhosis

Author

Combes, B, primary, Carithers, R L, additional, Maddrey, W C, additional, Lin, D, additional, McDonald, M F, additional, Wheeler, D E, additional, Eigenbrodt, E H, additional, Mu??oz, S J, additional, Rubin, R, additional, Garcia-Tsao, G, additional, Bonner, G F, additional, West, A B, additional, Boyer, J L, additional, Luketic, V A, additional, Shiffman, M L, additional, Mills, A S, additional, Peters, M G, additional, White, H M, additional, Zetterman, R K, additional, Rossi, S S, additional, Hofmann, A F, additional, and Markin, R S, additional

Published
1995
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16. Evaluation of drug-induced serious hepatotoxicity (eDISH): application of this data organization approach to phase III clinical trials of rivaroxaban after total hip or knee replacement surgery.

Author

Watkins PB, Desai M, Berkowitz SD, Peters G, Horsmans Y, Larrey D, Maddrey W, Watkins, Paul B, Desai, Mehul, Berkowitz, Scott D, Peters, Gary, Horsmans, Yves, Larrey, Dominique, and Maddrey, Willis

Abstract

Background: The most specific indicator of a drug-induced liver injury signal in a clinical trial database is believed to be the occurrence of subjects experiencing drug-associated elevations in both serum ALT and serum total bilirubin (TB) without a significant elevation in serum alkaline phosphatase (ALP). eDISH (evaluation of Drug-Induced Serious Hepatotoxicity) is a recently described tool that organizes liver laboratory data by graphically displaying peak serum ALT and TB levels for each subject, and can also provide direct links to the pertinent clinical and laboratory data for each subject.Objective: To illustrate the usefulness of the eDISH approach in the presentation of liver safety data by using phase III clinical trial data for rivaroxaban.Methods: Four randomized, active-controlled studies were conducted worldwide in subjects undergoing elective hip or knee replacement surgery to compare the efficacy and safety of the anticoagulant rivaroxaban, an oral, direct Factor Xa inhibitor, with the low-molecular-weight heparin, enoxaparin. Liver laboratory assessments, including ALT, AST, TB and ALP, were performed frequently during the studies. Data were incorporated into eDISH and linked data for selected subjects were analysed.Results: In the pooled analysis of the four studies, a total of 12 262 subjects (6131 rivaroxaban, 6131 enoxaparin) received at least one dose of study drug and had at least one central and/or local laboratory assessment during the study. A total of 143 (2.33%) rivaroxaban subjects and 223 (3.64%) enoxaparin subjects experienced a peak ALT >3 × upper limit of normal (ULN) but did not experience an elevation of TB >2 × ULN; these subjects are displayed in the right lower quadrant of the eDISH plot, termed the 'Temple's Corollary quadrant'. There were ten rivaroxaban and ten enoxaparin subjects with a peak ALT >3 × ULN and a peak TB >2 × ULN; these subjects were displayed in the right upper quadrant of the eDISH plot, termed the 'Hy's Law quadrant'. eDISH allowed efficient examination of the relevant data for each of these subjects.Conclusions: The eDISH approach is an efficient and effective way to organize and examine large liver safety databases for randomized controlled clinical trials. It greatly facilitates a systematic and transparent examination of the relevant liver safety laboratory data. We believe eDISH should become a standard approach for assessing and studying liver safety issues in clinical trials. [ABSTRACT FROM AUTHOR]

Published
2011
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20. Update in hepatology.

Author

Maddrey, Willis C. and Maddrey, W C

Subjects
*HEPATITIS viruses, *LIVER diseases, *INFORMATION resources, *HEPATITIS A transmission, *HEPATITIS B prevention, *HEPATITIS B transmission, *HEPATITIS C diagnosis, *HEPATITIS C treatment, *HEMOCHROMATOSIS, *HEPATITIS A, *HEPATITIS B, *HEPATITIS C, *GENOTYPES
Abstract

Provides sources of information that summarize advancements made in hepatology over the past two years. Hepatitis A; Hepatitis B; Hepatitis C; Hemochromatosis; 'HAV is Easily Spread,' by Y.J. Hutin, V. Pool, E.H. Cramer; 'Vaccinating Patients with Chronic Liver Disease against HAV Is Important,' by E.B. Keeffe, S. Iwarson, B.J. McMahon.

Published
2001
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22. False positive ELISA tests for anticardiolipin antibodies in sera from patients with repeated abortion, rheumatologic disorders and primary biliary cirrhosis: correlation with elevated polyclonal IgM and implications for patients with repeated abortion.

Author

Cowchock, S., Fort, J., Munoz, S., Norberg, R., and Maddrey, W.

Subjects
ENZYME-linked immunosorbent assay, IMMUNOGLOBULIN M, CIRRHOSIS of the liver, ANTIGENS, RHEUMATOLOGY, PHOSPHOLIPIDS
Abstract

Non-specific binding in an ELISA test for antibodies to cardiolipin (ACA) was investigated in sera from patients with primary biliary cirrhosis, rheumatological disorders, and repeated abortion. Binding to wells without phospholipid was most frequent in ELISA assay for IgM class ACA and correlated with levels of serum polyclonal IgM in patients with repeated abortion and rheumatologic disorders (r = 0.79, 0.76). Using added polyclonal IgM we demonstrated that the increase in non-specific binding was most significant when levels of ACA were low; subtraction of binding to the unoccupied well over-corrected specific antibody estimates when a high affinity antibody was present. Absorption studies on three sera suggest that this 'non-specific' binding includes low affinity antibody binding. Elevated levels of polyclonal IgM in sera from patients with repeated abortion may account for some reports of elevated IgM class antibodies in other ELISA assays. The prevalence of a positive test for ACA in a sequential series of 412 such patients was reduced to 6.1% (95% confidence limits 4-9%) after subtraction of non-specific binding. [ABSTRACT FROM AUTHOR]

Published
1988

23. A Comparison of Bumetanide and Furosemide in the Treatment of Ascites. Cooperative Study.

Author

HERLONG, H. F., HUNTER, F. M., KOFF, R. S., and MADDREY, W. C.

Abstract

In a cooperative study by clinicians in three medical facilities, bumetanide was compared with furosemide in patients presenting with ascites, a complication of chronic liver disease. In an open, parallel, randomized trial, 43 patients received bumetanide and 16 patients received furosemide. They were treated for from one to 28 weeks. Weight loss and decrease in abdominal girth following diuretic action occurred in both groups but was statistically significant only in the bumetanide treated patients. Because of the small number of patients on furosemide, valid statistical analysis could not be obtained. No evidence of hepatic encephalopathy developed during this study, and only one patient on furosemide was discontinued as a result of severe electrolyte imbalance. Differences in changes of electrolytes and uric acid were not statistically significant in the two groups. The majority of drug-related abnormalities were the result of the pharmacologic activity of the diuretic. [ABSTRACT FROM AUTHOR]

Published
1981
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26. Interferon-alpha2b therapy is efficacious in Asian-Americans with chronic hepatitis B infection: a prospective controlled trial.

Author

Martin, P, Hann, H W, Westerberg, S, Muñoz, S J, Rubin, R, and Maddrey, W C

Abstract

Chronic hepatitis B virus infection is endemic in Asian communities in the United States. The purpose of the current study was to compare the antiviral efficacy of interferon-alpha2b in a group of adult Asian patients chronically infected with hepatitis B with active replication compared to a control group of Caucasian patients treated with the same regimen. Patients with entry aminotransferase (ALT) levels greater than three times the upper limit of normal received interferon-alpha2b, 5 million units, subcutaneously daily for 16 weeks. Patients with pretreatment ALT levels 1.5-3 times the upper limit of normal received prednisone for a total of six weeks prior to interferon starting at 60 mg daily with reduction in dosage by 20 mg every two weeks with a two-week period between finishing prednisone and starting interferon-alpha2b. Eight (62%) of the 13 Asians and six (60%) of the 10 Caucasians cleared HBeAg and HBV DNA from serum (NS). By the end of one year of follow-up after therapy, four (67%) of six Caucasian responders but none of the Asian responders had cleared hepatitis B surface antigen from serum (P < 0.05). Loss of serum markers of active replication appeared less durable in the Asian responders compared to the Caucasians with reappearance of serum HBeAg in two (25%) of eight of the former but only one (17%) of the latter group. Three other Asian patients subsequently redeveloped HBeAg in serum. It is concluded that adult Asian-Americans have an identical initial response rate to antiviral therapy with interferon-alpha2b; however, the response may be less durable and does not usually lead to loss of HBsAg. [ABSTRACT FROM AUTHOR]

Published
1998

27. Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial.

Author

Carithers Jr., Robert I., Herlong, Franklin, Diehl, Anna Mae, Shaw, Ellen W., Combes, Burton, Fallon, Harold J., Maddrey, Willis C., Carithers, R L Jr, Herlong, H F, Diehl, A M, Shaw, E W, Combes, B, Fallon, H J, and Maddrey, W C

Subjects
ADRENOCORTICAL hormones, HEPATITIS, ALCOHOLIC liver diseases
Abstract

Study Objective: To determine the efficacy of a corticosteroid in reducing the short-term mortality of patients with severe alcoholic hepatitis.Design: Randomized, double-blind, placebo-controlled multicenter trial.Setting: Four university teaching hospitals.Patients: We enrolled 66 patients with alcoholic hepatitis and either spontaneous hepatic encephalopathy or a discriminant function value greater than 32, calculated using the formula: 4.6 (prothrombin time - control time) + serum bilirubin [in mumol/L]/17.1. Fifty-nine patients (89%) completed the study. Two patients withdrew from the trial. The other 64 patients were hospitalized for the duration of the trial; however, treatment was discontinued in 5 patients because of potential drug toxicity.Interventions: Patients were randomly assigned to receive either methylprednisolone (32 mg) or placebo within 7 days of admission. Treatment was given for 28 days. The doses were then tapered over 2 weeks and discontinued.Measurements and Main Results: The endpoint of the study was death. Of the 31 recipients of placebo, 11 (35%) died within 28 days of randomization compared with 2 (6%) of the 35 patients given methylprednisolone (P = 0.006). The 95% CI for the difference in mortality was 12% to 70%. In the patients with spontaneous hepatic encephalopathy at entry, 9 of 19 recipients of placebo died (47%) compared with 1 (7%) of the 14 patients given methylprednisolone (P = 0.02). The 95% CI for the difference in mortality was 14% to 66%. The Cox proportional hazards regression model showed the advantage of methylprednisolone over placebo after adjustment for other potentially important prognostic variables (P = 0.004).Conclusions: Methylprednisolone therapy decreases short-term mortality in patients with severe alcoholic hepatitis manifested either by spontaneous hepatic encephalopathy or a markedly elevated discriminant function value. [ABSTRACT FROM AUTHOR]

Published
1989
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28. Isoniazid hepatitis.

Author

Maddrey, Willis S., Boitnott, John K., Maddrey, W C, and Boitnott, J K

Subjects
HEPATITIS, ISONIAZID, ANTITUBERCULAR agents, TUBERCULOSIS prevention, ALKALINE phosphatase, ASPARTATE aminotransferase, BILIRUBIN, DRUG allergy, JAUNDICE, LIVER, CIRRHOSIS of the liver, CASE studies, TIME, RETROSPECTIVE studies, PROTHROMBIN time, THERAPEUTICS
Abstract

Examines some cases of hepatitis secondary to isoniazid given for the treatment of tuberculosis. Medical history of patients; Clinical features; Side effects of izoniazid.

Published
1973
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29. Coincidental Australia antigenemia in primary biliary cirrhosis.

Author

Maddrey, Willis C., Saito, Shozo, Shulman, N. Raphael, Klatskin, Gerald, Maddrey, W C, Saito, S, Shulman, N R, and Klatskin, G

Subjects
HEPATITIS viruses, BILE, HEPATITIS associated antigen, IMMUNOGLOBULINS
Abstract

Presents a study that investigated the role of the long-incubation hepatitis virus in the pathogenesis of primary biliary cirrhosis. Examination of Australia antigen and antibody in the serum of patients with the disease; Techniques used in the study; Detection of antimitochondrial antibody.

Published
1972
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31. Primary biliary cirrhosis: new perspectives

Author

Maddrey, W. C.

Subjects
Male, Liver Cirrhosis, Biliary, Humans, Vitamins, Middle Aged, Antibodies, Research Article, Liver Transplantation, Mitochondria
Published
1989

32. False positive ELISA tests for anticardiolipin antibodies in sera from patients with repeated abortion, rheumatologic disorders and primary biliary cirrhosis: correlation with elevated polyclonal IgM and implications for patients with repeated abortion

Author

Cowchock, S, Fort, J, Munoz, S, Norberg, R, and Maddrey, W

Subjects
Adult, Male, Abortion, Habitual, Adolescent, Cardiolipins, Liver Cirrhosis, Biliary, Antibody Affinity, Enzyme-Linked Immunosorbent Assay, Immunoglobulin M, Antibody Specificity, Pregnancy, Rheumatic Diseases, Humans, False Positive Reactions, Female, Research Article, Autoantibodies
Abstract

Non-specific binding in an ELISA test for antibodies to cardiolipin (ACA) was investigated in sera from patients with primary biliary cirrhosis, rheumatological disorders, and repeated abortion. Binding to wells without phospholipid was most frequent in ELISA assay for IgM class ACA and correlated with levels of serum polyclonal IgM in patients with repeated abortion and rheumatologic disorders (r = 0.79, 0.76). Using added polyclonal IgM we demonstrated that the increase in non-specific binding was most significant when levels of ACA were low; subtraction of binding to the unoccupied well over-corrected specific antibody estimates when a high affinity antibody was present. Absorption studies on three sera suggest that this 'non-specific' binding includes low affinity antibody binding. Elevated levels of polyclonal IgM in sera from patients with repeated abortion may account for some reports of elevated IgM class antibodies in other ELISA assays. The prevalence of a positive test for ACA in a sequential series of 412 such patients was reduced to 6.1% (95% confidence limits 4-9%) after subtraction of non-specific binding.

Published
1988

33. Aprindine hepatitis.

Author

Herlong, H. Franklin, Reid, Philip R., Boitnott, John K., Madorey, Willis C., Herlong, H F, Reid, P R, Boitnott, J K, and Maddrey, W C

Subjects
HEPATITIS, MYOCARDIAL depressants, PATIENTS, ARRHYTHMIA, HYDROCARBONS, LIVER, THERAPEUTICS
Abstract

We have seen two patients whose hepatitis was due to the administration of aprindine, a new antiarrhythmic agent. In both patients evidence of hepatitis appeared within 3 weeks of initiating aprindine therapy and resolved rapidly when the drug was withdrawn. The reintroduction of aprindine in one patient was associated with the reappearance of hepatitis, which resolved despite continued administration of the drug. [ABSTRACT FROM AUTHOR]

Published
1978
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46. The case for simplifying and using absolute targets for viral hepatitis elimination goals

Author

Tsendsuren S. Oyunsuren, Chari Cohen, Waseem Hamoudi, Yao‐Chun Hsu, Harry L.A. Janssen, Hisham El Khayat, Manal H El-Sayed, Wan-Long Chuang, Young-Suk Lim, Mohamed Hassany, Fernando Passos Cupertino de Barros, Faisal Abaalkhail, Stefan Zeuzem, Samual S Lee, Miriam T. Levy, Imam Waked, Vassiliki Papaevangelou, James Fung, Erika Castro Batänjer, Kathryn Razavi-Shearer, Boatemaa Ntiri‐ Reid, Rosmawati Mohamed, Pagbajabyn Nymadawa, Robert Flisiak, Alnoor Ramji, Carole Seguin-Devaux, Sherif Mogawer, Béla Hunyady, Huma Qureshi, Mojca Matičič, Martin Lagging, Mark W. Sonderup, Xiaoguang Dou, Anne Oevrehus, William Sievert, Ezequiel Ridruejo, Ann-Sofi Duberg, Ahad Eshraghian, R. P. Shanmugam, Arif Nawaz, Qing Xie, Rick Dunn, Sayed Himatt, Daniel Shouval, Mendez Sanchez Nahum, Sabahattin Kaymakoglu, Vincent Wai-Sun Wong, Soek-Siam Tan, Willis Maddrey, Papu Prasad, Amjad Salamat, Stephanie Popping, Alice Lee, Maurizia Rossana Brunetto, Khalid Alswat, Peyton Thompson, Dong Joon Kim, Henry Chang, Amir Ali Sohrabpour, Ellen Dugan, Peer Brehm Christensen, David A. M. C. van de Vijver, Joaquín Cabezas, Su Wang, Ala I. Sharara, Peter Jarcuska, Karine Lacombe, Danjuma Adda, Sammy Saab, Chien-Jen Chen, Hwai I. Yang, Sanaa Said, Raymond F. Schinazi, Shyamasundaran Kottilil, Graham R. Foster, Qing Ning, Mehlika Toy, Ira M. Jacobson, Ayat R. Abdallah, Laura Cisneros, Dhondup Tashi, Naveed Z. Janjua, Moutaz Derbala, Marcelo Kugelmas, Steven L. Flamm, Angelos Hatzakis, Yusuf Yilmaz, Mark S. Sulkowski, Eugene R. Schiff, Kakharman Yesmembetov, John F. Dillon, Rittoo Prithiviputh, Carlos Eduardo Brandão-Mello, Rajender Reddy, Françoise Roudot-Thoraval, Lewis R. Roberts, Javier Crespo, Massimo Colombo, Nancy Steinfurth, I. M. Hoepelman, Kosh Agarwal, Faisal M. Sanai, Waleed Al-Hamoudi, Shuang Liu, Beat Muellhaupt, Sonjelle Shilton, Curtis Cooper, Calvin Q. Pan, Aijaz Ahmed, Wai-cheung C Lao, Alejandro Soza, Patricia Vélez‐Möller, Ibrahim Altraif, Tarik Asselah, Junko Tanaka, Badr Aljarallah, Adriana Vince, Faryal Khamis, Juan Francisco Sánchez-Ávila, Rafael Esteban Mur, Kimberly A. Brown, Saad Al-Kaabi, Ming-Lung Yu, Jonas Valantinas, Marieta Simonova, Javier García-Samaniego, Do Young Kim, Ieva Tolmane, Valentina Liakina, Antonio Craxì, Devin Razavi-Shearer, Waldemar Halota, Stuart K. Roberts, Donna Cryer, Kenneth Kabagambe, William Remak, Jeffrey V. Lazarus, Brian Conway, Sameera Ezzat, C Wendy Spearman, Karolin Falconer, Maria C Mendes Correa, Poonam Mathur, Ferruccio Bonino, Jose Luis Calleja, Said A. Al-Busafi, E. A. Croes, Tim Block, Shahin Merat, Francesco Negro, Reza Malekzadeh, Fernando L. Gonçales, Amany Zekry, Wahid Doss, Michael Ninburg, Philip Bruggmann, Man-Fung Yuen, George V. Papatheodoridis, Aasim Yusuf, David Kershenobich, Bruce R. Bacon, Abdul Rahman Bizri, Gamal Esmat, Sarah Blach, Hamad Al-Romaihi, Tatsuya Kanto, Ibrahim Mostafa, Homie Razavi, Alessio Aghemo, Mauricio Orrego, Jia-Horng Kao, Daniel Lavanchy, Zobair M. Younossi, Henry Lik-Yuen Chan, Anna Kramvis, David H. Muljono, Clemens Richter, Hla-Hla Thein, Fernando Bessone, Paulo Roberto Abrão Ferreira, Geoffrey Dusheiko, Susan Hay, Geert Robaeys, Eduardo Fassio, Loreta A. Kondili, Jorge Mera, Khalid Al-Naamani, Alaa Osman, Saleh A. Alqahtani, Joseph Doyle, Necati Örmeci, Yee Tak Hui, Heiner Wedemeyer, Laith Jamal Abu Raddad, Masayuki Kurosaki, Rui Tato Marinho, Robert G. Gish, Zaigham Abbas, Seiji Yamada, Giada Sebastiani, Cihan Yurdaydin, Maria Buti, Paulo Ferrinho, Razavi H., Blach S., Razavi-Shearer D., Abaalkhail F., Abbas Z., Abdallah A., Abrao Ferreira P., Abu Raddad L.J., Adda D., Agarwal K., Aghemo A., Ahmed A., Al-Busafi S.A., Al-hamoudi W., Al-Kaabi S., Al-Romaihi H., Aljarallah B., AlNaamani K., Alqahtani S., Alswat K., Altraif I., Asselah T., Bacon B., Bessone F., Bizri A.R., Block T., Bonino F., Brandao-Mello C.E., Brown K., Bruggmann P., Brunetto M.R., Buti M., Cabezas J., Calleja J.L., Castro Batanjer E., Chan H.L.-Y., Chang H., Chen C.-J., Christensen P.B., Chuang W.-L., Cisneros L., Cohen C., Colombo M., Conway B., Cooper C., Craxi A., Crespo J., Croes E., Cryer D., Cupertino de Barros F.P., Derbala M., Dillon J., Doss W., Dou X., Doyle J., Duberg A.-S., Dugan E., Dunn R., Dusheiko G., El Khayat H., El-Sayed M.H., Eshraghian A., Esmat G., Esteban Mur R., Ezzat S., Falconer K., Fassio E., Ferrinho P., Flamm S., Flisiak R., Foster G., Fung J., Garcia-Samaniego J., Gish R.G., Goncales F., Halota W., Hamoudi W., Hassany M., Hatzakis A., Hay S., Himatt S., Hoepelman I.M., Hsu Y.-C., Hui Y.T., Hunyady B., Jacobson I., Janjua N., Janssen H., Jarcuska P., Kabagambe K., Kanto T., Kao J.-H., Kaymakoglu S., Kershenobich D., Khamis F., Kim D.J., Kim D.Y., Kondili L.A., Kottilil S., Kramvis A., Kugelmas M., Kurosaki M., Lacombe K., Lagging M., Lao W.-C., Lavanchy D., Lazarus J.V., Lee A., Lee S.S., Levy M., Liakina V., Lim Y.-S., Liu S., Maddrey W., Malekzadeh R., Marinho R.T., Mathur P., Maticic M., Mendes Correa M.C., Mera J., Merat S., Mogawer S., Mohamed R., Muellhaupt B., Muljono D., Mostafa I., Nahum M.S., Nawaz A., Negro F., Ninburg M., Ning Q., Ntiri- Reid B., Nymadawa P., Oevrehus A., Ormeci N., Orrego M., Osman A., Oyunsuren T., Pan C., Papaevangelou V., Papatheodoridis G., Popping S., Prasad P., Prithiviputh R., Qureshi H., Ramji A., Razavi-Shearer K., Reddy R., Remak W., Richter C., Ridruejo E., Robaeys G., Roberts S., Roberts L., Roudot-Thoraval F., Saab S., Said S., Salamat A., Sanai F., Sanchez-Avila J.F., Schiff E., Schinazi R., Sebastiani G., Seguin-Devaux C., Shanmugam R.P., Sharara A., Shilton S., Shouval D., Sievert W., Simonova M., Sohrabpour A.A., Sonderup M., Soza A., Wendy Spearman C., Steinfurth N., Sulkowski M., Tan S.-S., Tanaka J., Tashi D., Thein H.-H., Thompson P., Tolmane I., Toy M., Valantinas J., Van de Vijver D., Velez-Moller P., Vince A., Waked I., Wang S., Wedemeyer H., Wong V., Xie Q., Yamada S., Yang H.-I., Yesmembetov K., Yilmaz Y., Younossi Z., Yu M.-L., Yuen M.-F., Yurdaydin C., Yusuf A., Zekry A., Zeuzem S., Medical Microbiology & Infectious Diseases, Virology, and Negro, Francesco

Subjects
ddc:616, Carcinoma, Hepatocellular, Hepatology, Hepatitis, Viral, Human, business.industry, Liver Neoplasms, ddc:616.07, medicine.disease, World Health Organization, Virology, digestive system diseases, Goal, Infectious Diseases, Absolute (philosophy), SDG 3 - Good Health and Well-being, medicine, Humans, Viral hepatitis, business, Goals, Human
Abstract

The 69th World Health Assembly endorsed the Global Health Sector Strategy for Viral Hepatitis, embracing a goal to eliminate hepatitis infection as a public health threat by 2030. This was followed by the World Health Organization's (WHO) global targets for the care and management of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. These announcements and targets were important in raising awareness and calling for action; however, tracking countries’ progress towards these elimination goals has provided insights to the limitations of these targets. The existing targets compare a country's progress relative to its 2015 values, penalizing countries who started their programmes prior to 2015, countries with a young population, or countries with a low prevalence. We recommend that (1) WHO simplify the hepatitis elimination targets, (2) change to absolute targets and (3) allow countries to achieve these disease targets with their own service coverage initiatives that will have the maximum impact. The recommended targets are as follows: reduce HCV new chronic cases to ≤5 per 100000, reduce HBV prevalence among 1-year-olds to ≤0.1%, reduce HBV and HCV mortality to ≤5 per 100000, and demonstrate HBV and HCV year-to-year decrease in new HCV- and HBV-related HCC cases. The objective of our recommendations is not to lower expectations or diminish the hepatitis elimination standards, but to provide clearer targets that recognize the past and current elimination efforts by countries, help measure progress towards true elimination, and motivate other countries to follow suit.

Published
2021
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47. Adult hepatitis B vaccination using a novel triple antigen recombinant vaccine.

Author

Young MD, Schneider DL, Zuckerman AJ, Du W, Dickson B, and Maddrey WC

Subjects
Adult, Antibody Formation, Double-Blind Method, Female, Hepatitis B Antibodies biosynthesis, Humans, Male, Middle Aged, Prospective Studies, Recombinant Proteins, Risk Factors, Antigens, Viral therapeutic use, Hepatitis B prevention & control, Vaccination adverse effects, Viral Vaccines therapeutic use
Abstract

Present hepatitis B vaccines use multidose prolonged regimens, which even healthcare workers at risk do not always complete. Moreover, when vaccination is completed there remain some who fail to achieve adequate protection. The protection of adults at risk could be improved if there were a more potent vaccine and/or a shorter vaccination regimen available. Vaccine-naive adults were randomized to vaccination with either Engerix-B (SmithKline Biologicals, Rixensart, Belgium) or a novel triple antigen (S, pre-S1, and pre-S2) recombinant vaccine (Hepacare; Medeva Pharma Plc, Speke, UK). The primary efficacy parameter was the degree of seroprotection 6 or 7 months (26 +/- 2 weeks) after beginning vaccination. A total of 304 adults entered the study. Of these, 16 failed to complete the study (9 on Hepacare and 7 on Engerix-B). With the Engerix-B standard (0, 1, 6) regimen, 88% of subjects were protected by month 7, whereas with the triple antigen vaccine a 2-dose regimen (0, 1) provided equivalent protection (91%) within 6 months and a 3-dose (0, 1, 6) regimen was significantly superior (98% seroprotected by 7 months after starting vaccination P <.001). With adults at risk for a suboptimal response (i.e., older adults, the obese, men, and smokers) the triple antigen vaccine produced a greater degree of protection. The vaccines had similar safety profiles. Both vaccines were well tolerated. In healthy normal adults, a triple antigen hepatitis B vaccine containing S and pre-S antigens produced an enhanced immunologic response and was as effective as a 2- and 3-dose regimen.

Published
2001
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48. Comparison of a triple antigen and a single antigen recombinant vaccine for adult hepatitis B vaccination.

Author

Young MD, Gooch WM 3rd, Zuckerman AJ, Du W, Dickson B, and Maddrey WC

Subjects
Adolescent, Adult, Aged, Double-Blind Method, Female, Hepatitis B Vaccines administration & dosage, Humans, Immunization Schedule, Logistic Models, Male, Middle Aged, Time Factors, Vaccines, Synthetic administration & dosage, Vaccines, Synthetic immunology, Hepatitis B prevention & control, Hepatitis B Antibodies biosynthesis
Abstract

Hepatitis B and its sequelae are a major public health problem. Vaccines have been available for almost 20 years; however the disease still remains a global problem. Many factors contribute to the failure to control hepatitis B, including the limited nature of the vaccination programs implemented initially. Only relatively recently has mass childhood vaccination begun to be implemented and vaccination of high-risk groups, other than healthcare workers, is still not general policy. Additional factors contributing to continued persistence of hepatitis B in the developed world are that the present vaccines are not fully used by those recommended to be vaccinated and even when vaccination is carried out appropriately, there remain some who fail to achieve adequate protection. Clearly, the protection of at-risk groups who have inadequate response to current vaccines, and those who are unwilling or unable to comply with protracted multi-dose vaccine regimens, could be improved if there were a more potent vaccine and/or a shorter vaccination regimen available. Adults who had never been vaccinated against hepatitis B were randomised to receive a vaccination course of either a present single antigen (S) vaccine (Recombivax-HB) or a novel triple antigen (S, pre-S1, and pre-S2) recombinant vaccine (Hepacare Medeva Pharma plc). Doses were given at baseline and 1 month and 6 months later. Hepatitis B surface antibody (anti-HBs) levels were measured at 2, 4, 6, and 7 months after beginning vaccination. The primary efficacy parameter was the degree of protection, measured as the percentage of subjects with anti-HBs titres > or = 10 IU/L, 6 or 7 months (26 +/- 2 weeks) after beginning vaccination. A total of 303 adult subjects entered the study and were vaccinated. Of these, 11 failed to complete the study (4 on Hepacare and 7 on Recombivax-HB); however all but 2 (1 to receive the triple antigen vaccine and 1 to receive Recombivax-HB) were included in the intent-to-treat population for efficacy evaluation. Treatment randomisation was stratified at entry based on age (above and below 40 years old) and gender. The standard three-dose/6-month vaccination regimen of the single antigen vaccine protected 83% of subjects by 7 months after starting vaccination whereas the triple antigen vaccine as a two-dose/1-month regimen protected 88% within 6 months and as a three-dose/6-month regimen protected 97% by 7 months after starting vaccination. Thus the protection rate provided by the shortened (0, 1) regimen of the novel vaccine was "essentially equivalent" (i.e., not statistically inferior) to that provided by the full (0, 1, and 6) regimen of today's vaccine (88% vs. 81%, P < 0.001), and the protection rate provided by a three-dose/6-month (0, 1, and 6) regimen of the new vaccine was significantly superior to that provided by present vaccines (97% vs. 83% P < 0.001). The percentage of subjects protected increases with time after beginning vaccination and at all time points up to and including 6 months was significantly greater with the two-dose regimen of the triple antigen vaccine than with the single antigen vaccine regimen. In adults at risk for a reduced response to hepatitis B vaccination [i.e., older adults (>/=40), the obese, males, and smokers], the triple antigen vaccine produced a significantly greater percentage of protected subjects (P < 0.001) and higher geometric mean titre (P < 0.001). Indeed as a three-dose/6 month regimen, the triple antigen vaccine raised the level of protection in these vulnerable subgroups to that seen when a single antigen vaccine is used in the optimal younger adult group. Both vaccines were well tolerated and had similar safety profiles. The most frequently (> or = 10%) reported adverse events with the use of either vaccine were pain at the site of injection (38% vs. 41% vs. 20% for the two-dose Hepacare regimen, the three-dose Hepacare regimen, and the three-dose Recombivax-HB regimen, respectively), infections at the site of injection (1% vs. 14% vs. 9%), headache (9% vs. 13% vs. 11%), and nausea (7% vs. 11% vs. 3%). It is concluded that in healthy normal adults, a triple antigen hepatitis B vaccine that contained S and pre-S antigens produced an enhanced immunological response. This was exemplified by the novel vaccine's ability to overcome factors such as advancing age (> or = 40 years), obesity, and smoking, each of which is known to reduce the potential for protection with present recombinant S only vaccines. A two-dose/1-month (0 and 1) regimen of this triple antigen vaccine was as effective as the standard three-dose/6 month (0, 1, and 6) regimen of present single antigen vaccines. (c) 2001 Wiley-Liss, Inc.

Published
2001
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49. A multi-center controlled study of rapid hepatitis B vaccination using a novel triple antigen recombinant vaccine.

Author

Young MD, Rosenthal MH, Dickson B, Du W, and Maddrey WC

Subjects
Adolescent, Adult, Double-Blind Method, Female, Hepatitis B Antibodies biosynthesis, Hepatitis B Antibodies blood, Hepatitis B Surface Antigens administration & dosage, Hepatitis B Vaccines adverse effects, Humans, Immunization Schedule, Male, Middle Aged, Prospective Studies, Vaccines, Synthetic administration & dosage, Vaccines, Synthetic adverse effects, Hepatitis B Vaccines administration & dosage
Abstract

Hepatitis B vaccines have been available for 20 years, however, the disease still remains a global problem. Clearly, the protection of at-risk groups could be improved if a more potent vaccine with a shorter vaccination regimen were available. Hepacare is new recombinant vaccine, which contains three of the surface antigens of the HB virus and has higher immunogenicity than present single antigen (HBsAg only) vaccines. This study evaluates the potential for developing seroprotection rapidly and the viability of a 1 month/two dose regimen. A total of 400 adult subjects were vaccinated using either the present accelerated 2 month/three dose regimen of Engerix-B or a 1 month/two dose regimen of a novel triple antigen vaccine (Hepacare). Both vaccines were well tolerated. Four weeks after a single dose, the seroprotective rates for Engerix-B and the triple antigen vaccine were 5 and 17%, respectively. By month 2, 4 weeks after two doses of vaccine, it was 38 and 61%. Finally by month 3, 4 weeks after a third dose of Engerix-B or placebo, respectively, the seroprotection rates were 71 and 82%. The geometric mean titres (GMTs), of these responders was then 119 and 120 IU/l, respectively. Both vaccines were well tolerated. At all points up to and including 3 months after beginning vaccination, the novel 1 month/two dose regimen of Hepacare was significantly more effective in producing seroporotective titres than the 2 month/three dose regimen of Engerix-B (P = 0.001).

Published
2001
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50. Hepatitis B--an important public health issue.

Author

Maddrey WC

Subjects
Antiviral Agents therapeutic use, Carrier State, Endemic Diseases, Hepatitis B Vaccines, Hepatitis B, Chronic, Humans, Interferon-alpha adverse effects, Interferon-alpha therapeutic use, Lamivudine therapeutic use, Liver Diseases virology, Hepatitis B complications, Hepatitis B drug therapy, Hepatitis B epidemiology, Hepatitis B prevention & control, Public Health
Abstract

Hepatitis B is one of the most common infectious diseases in the world. It has been estimated that 350 million people worldwide are chronic hepatitis B virus (HBV) carriers. The global prevalence of chronic HBV infection varies widely, from high ( > 8%, e.g., Africa, Asia and the Western Pacific) to intermediate (2-7% e.g., Southern and Eastern Europe) and low (< 2%, e.g., Western Europe, North America and Australia). The predominant routes of transmission vary according to the endemicity of the HBV infection. In areas of high endemicity, perinatal transmission is the main route of transmission, whereas in areas of low endemicity, sexual contact amongst high-risk adults is predominant. Between one-third and one-quarter of people infected chronically with HBV are expected to develop progressive liver disease (including cirrhosis and primary liver cancer). Although mass vaccination programs have begun to control the spread of HBV infection, therapeutic intervention is the only option for those with established chronic HBV-associated liver disease. Until recently, the only treatment for chronic hepatitis B was the immune modulator, interferon (IFN) alpha. However, IFN alpha treatment has several disadvantages; it is expensive, it must be administered by injection, there are side-effects, and IFN alpha is poorly tolerated. Lamivudine, a nucleoside analogue, is the first effective, and well tolerated, oral treatment for chronic hepatitis B. In conclusion, although we are still some way from eradicating or curing chronic hepatitis B, the advent of lamivudine allows new populations to benefit from therapy and helps to address the global public health problem of hepatitis B.

Published
2001

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